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Tuesday, June 10, 2008

FDA to Renew Research on Bisphenol-A Effects

Late last week, FDA's lead scientist asked the agency's science board to convene a subcommittee to study the effects of bisphenol-A (BPA), a chemical commonly found in hard plastics and food containers. The science board is an advisory committee of non-governmental scientists who provide expert advice to FDA decision makers.

From the FDA press release, it appears as though the primary responsibility of the subcommittee will be to review an FDA task force report on BPA exposure and effects. "In April 2008, the FDA formed an agency-wide BPA Task Force to facilitate review of current research and new information on BPA," FDA says. After the subcommittee reviews the report this summer, "the task force will make recommendations" to the FDA commissioner.

The increased activity at FDA comes less than two months after a report by the National Toxicology Program (NTP), which, like FDA, is part of the Department of Health and Human Services, raised concern about the possible health effects of BPA.

The NTP report finds most humans are exposed to BPA and retain it in their bodies. The panel looked at studies of laboratory rodents exposed to BPA and found a wide variety of adverse health effects at high doses and other possible health effects at low doses — mostly developmental and reproductive abnormalities.

NTP concluded bisphenol-A is of "some concern" — a qualitative designation. Other options available to the panel included "serious concern" and "concern" for riskier substances, and "minimal concern" and "negligible concern" for less risky substances.

But FDA, which, unlike NTP, has the authority to regulate the chemical, isn't so sure. FDA has said on past occasions that BPA does not pose a "safety concern at the current exposure level."

A renewed effort within the agency to study BPA is a wise move, as is the decision to seek review from the agency's independent science advisors. FDA says its agency investigation will consult the NTP report as well as "available information on BPA in numerous other risk assessment documents from scientific and regulatory bodies worldwide."

Let's hope FDA keeps its pledge to limit its search to work from "scientific and regulatory bodies." In the past, FDA has relied on industry studies, according to congressional investigators. The House Energy and Commerce Committee wrote to FDA in January asking the agency to identify the basis on which it has made its decision that BPA is not harmful. FDA identified two studies, both of which were funded by the American Chemistry Council. One study had never been published or subjected to peer review.

Reg•Watch Update: "FDA Would Regulate BPA If Found Harmful, Official Says"